This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1

Subjects who are candidates for standard first-line therapy initiating with sunitinib

Time from diagnosis to treatment < 1 year

Karnofsky performance status (KPS) ≥ 70%

Life expectancy of 6 months or greater

Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Adequate hematologic, renal, hepatic, and coagulation function

Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug

Normal ECG or clinically non-significant finding(s) at Screening

Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Key Exclusion Criteria for Treatment Study:

Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy

Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA

History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease

Patients with 4 or more of the following risk factors:

Hgb < LLN

Corrected calcium > 10.0 mg/dL

KPS < 80%

Neutrophils > ULN

Platelets > ULN

Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)

Current treatment with an investigational therapy on another clinical trial

Pregnancy or breastfeeding

Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582672